Emergency use authorisation of Covid-19 vaccines: An ethical conundrum.

Large-scale vaccination with a safe and effective vaccine against Covid-19 is the only way to conquer the ongoing lethal pandemic that has led to extraordinary social and economic upheaval globally. Fortunately, the world is on the verge of developing Covid-19 vaccines in an unprecedentedly short time. More than forty vaccines are in different stages of clinical trials, and a few are in the crucial phase III studies stage. A new demand for emergency use authorisation and rapid deployment of these vaccines before scrutinising phase III trial data is raging in different quarters. Can advancement of the deployment of these vaccines by even a few weeks give us rich public health dividends? Would it be ethical to deploy these novel vaccines based only on the safety and immunogenicity data generated by the phase-I and II clinical trials? Would it be ethical to deny vaccination of vulnerable populations against an untreatable infectious disease despite the availability of reasonably safe and efficacious vaccines for the want of phase III trial data? The answer is not straightforward, as there are many complexities involved. This commentary attempts to discuss some ethical issues involved in a decision to deploy Covid-19 vaccination before phase III trial results are declared.

State Preparedness for Crisis Standards of Care in the United States: Implications for Emergency Management.

State governments and hospital facilities are often unprepared to handle a complex medical crisis, despite a moral and ethical obligation to be prepared for disaster. The 2019 novel coronavirus disease (COVID-19) has drawn attention to the lack of state guidance on how hospitals should provide care in a crisis. When the resources available are insufficient to treat the current patient load, crisis standards of care (CSC) are implemented to provide care to the population in an ethical manner, while maintaining an ability to handle the surge. This Editorial aims to raise awareness concerning a lack of preparedness that calls for immediate correction at the state and local level.Analysis of state guidelines for implementation of CSC demonstrates a lack of preparedness, as only five states in the US have appropriately completed necessary plans, despite a clear understanding of the danger. States have a legal responsibility to regulate the medical care within their borders. Failure of hospital facilities to properly prepare for disasters is not a new issue; Hurricane Katrina (2005) demonstrated a lack of planning and coordination. Improving disaster health care readiness in the United States requires states to create new policy and legislative directives for the health care facilities within their respective jurisdictions. Hospitals should have clear directives to prepare for disasters as part of a "duty to care" and to ensure that the necessary planning and supplies are available to their employees.

[Ethics of clinical trials]. / L'éthique des essais thérapeutiques.

TITLE: L'éthique des essais thérapeutiques. ABSTRACT: La pandémie de COVID-19 a conduit certains acteurs reconnus de la médecine à renoncer aux méthodes codifiées de la recherche médicale au profit d'affirmations établies dans l'urgence et sans réelle évaluation scientifique. Autant l'on peut comprendre que certains praticiens recourent à ce qui leur est ainsi proposé, autant cette confusion entre action dans l'urgence et recherche scientifique serait lourde de conséquences si elle venait à se généraliser, et cela à de multiples points de vue : image et rôle de la science, qualité et éthique de la recherche médicale et en fin de compte sort des malades soumis à des traitements mal évalués. Ce sont ces questions qui motivent la mise au point qui suit sur les questions d'éthique associées de longue date aux « essais thérapeutiques ¼, cette procédure rationnelle d'acquisition dans les meilleurs délais d'informations fiables sur les avantages et les risques des traitements dont on envisage l'éventuelle utilisation.

Obstetric hospital preparedness for a pandemic: an obstetric critical care perspective in response to COVID-19.

The Coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic has had a rapid and deadly onset, spreading quickly throughout the world. Pregnant patients have had high mortality rates, perinatal losses, and Intensive Care Unit (ICU) admissions from acute respiratory syndrome Coronavirus (SARS-CoV) and Middle East respiratory syndrome Coronavirus (MERS-CoV) in the past. Potentially, a surge of patients may require hospitalization and ICU care beyond the capacity of the health care system. This article is to provide institutional guidance on how to prepare an obstetric hospital service for a pandemic, mass casualty, or natural disaster by identifying a care model and resources for a large surge of critically ill pregnant patients over a short time. We recommend a series of protocols, education, and simulation training, with a structured and tiered approach to match the needs for the patients, for hospitals specialized in obstetrics.

Ethics in the Covid-19 emergency: Examining rationing decisions.

Early last month, the Italian Society of Anaesthesia was forced to publish the above guideline (1) for the country's hospitals. Besides the rising cases of infection, the doctors realised that patients required up to 15-20 days of intensive care as the disease progressed (2). In the face of medical resource scarcities, the guideline established that everyone could not be saved from the coronavirus. And a massive death toll ensued.